MAUDE Adverse Event Report: ARTHREX, INC. 4.5X40MM PERIPHERAL SCREW, NON-LOCKING; SHOULDR PROSTH, REVERSE CONFIG

Model Number	4.5X40MM PERIPHERAL SCREW, NON-LOCKING
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/28/2024, it was reported by a sales representative via email that an ar-9564-2442-lat glenosphere and glenosphere set screw disengaged from the baseplate.The patient underwent surgery on (b)(6) 2023 for a reverse shoulder arthroplasty.Postoperatively the patient experienced pain and a ct scan revealed glenosphere and glenosphere set screw disengaged from the baseplate.On (b)(6) 2023, the patient underwent a revision surgery in which a new glenosphere along with humeral components were implanted.No further information was provided.Additional information received on 11/4/2024: during the revision surgery, the ar-9502f-39lcpc suturecup, the ar-9503-3942-3 humeral insert, the ar-9501-07p humeral stem, the ar-9582-20 modular post, the ar-9563-28 peripheral locking screw, the ar-9563-16 peripheral locking screw, the ar-9563-20 peripheral locking screw, the ar-9562-40nl peripheral locking screw, the ar-9580-2010-2s baseplate, and ar-9564-2442-lat glenosphere was removed.Both procedures were performed by the same surgeon and at the same facility.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Corrected information: b3 date of event.Additional information: d6a, d6b, g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: 4.5X40MM PERIPHERAL SCREW, NON-LOCKING
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20726301
• Report Number: 1220246-2024-08563
• Device Sequence Number: 20957292
• Product Code: PHX
• UDI-Device Identifier: 00888867296756
• UDI-Public: (01)00888867296756(11)230112(17)271231(10)15043766
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4.5X40MM PERIPHERAL SCREW, NON-LOCKING
• Device Catalogue Number: AR-9562-40NL
• Device Lot Number: 15043766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown